Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amico Lab, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
520 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Amico Lab, Inc. | 1985-12-12 | 520 | 0 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | 1985-12-06 | 526 | 0 |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Amico Lab, Inc. | 1985-12-06 | 514 | 0 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | 1985-12-06 | 514 | 0 |
| K842529 | AMIZYME-CMV KIT | Amico Lab, Inc. | 1985-12-06 | 526 | 0 |
| K842530 | AMIZYME-EBV TEST KIT | Amico Lab, Inc. | 1985-12-06 | 526 | 0 |
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | Amico Lab, Inc. | 1984-10-30 | 112 | 0 |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | Amico Lab, Inc. | 1984-10-01 | 95 | 0 |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | Amico Lab, Inc. | 1984-10-01 | 83 | 0 |
| K842532 | AMIZYME-ANA TEST KIT | Amico Lab, Inc. | 1984-09-20 | 84 | 0 |
| K842533 | AMIZYME-ANDNA TEST KIT | Amico Lab, Inc. | 1984-09-20 | 84 | 0 |
| K842528 | AMIZYME-TOXOPLASMA GONDII KIT | Amico Lab, Inc. | 1984-09-07 | 71 | 0 |
| K842527 | AMIZYME-SCHISTOSOMA SPP. TEST KIT | Amico Lab, Inc. | 1984-09-05 | 69 | 0 |
| K842526 | AMIZYME-LEISHMANIA SPP. TEST KIT | Amico Lab, Inc. | 1984-08-28 | 61 | 0 |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | Amico Lab, Inc. | 1984-08-28 | 49 | 0 |
| K840024 | WHEELCHAIR MECHANICAL | Amico Lab, Inc. | 1984-01-30 | 25 | 0 |
| K822681 | ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) | Amico Lab, Inc. | 1982-12-13 | 101 | 0 |
| K822682 | ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K | Amico Lab, Inc. | 1982-12-03 | 91 | 0 |
| K822668 | ANTISERUM TO HUMAN IGA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822676 | FITC ANTISERA TO HUMAN IGG | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822666 | ANTISERUM TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822677 | FITC ANTISERA TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822673 | FITC ANTISERA TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822670 | ANTISERUM TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822667 | ANTISERUM TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822674 | FITC ANTISERA TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822679 | FITC ANTISERA TO HUMAN C3 | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822669 | ANTISERUM TO HUMAN IGG | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822678 | FITC ANTISERA TO HUMAN GOBULIN | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K823121 | RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA | Amico Lab, Inc. | 1982-11-17 | 23 | 0 |
| K822671 | ANTISERUM TO HUMAN GOBULIN | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822675 | FITC ANTISERA TO HUMAN IGA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda